Organ transplantation act to regulate tissue transplantation too

 The President of India gave her assent to the amended, more comprehensive bill on human organ transplantation in the first week of November. The new Act that will be called the Human Organs Transplantation (Amendment) Act, 2011, now includes standards for transplantation of tissues like bones, skin, heart valve and cornea besides organs like heart, liver, pancreas and kidneys. 

The rules for the Act will be ready in three months, informs Sudhir Gupta, additional deputy director general, directorate of health services under the Union health ministry. The existing rules for organ transplantation under the 1994 Act will be modified and new rules for tissue transplantation will be drafted within three months, he adds.  

While organ transplant is a life-saving measure in case of organ failure in humans, tissue transplant in most cases is crucial for patients suffering from different physical disabilities and it improves their quality of life. 

Skin transplant is needed for victims of severe burns. People suffering from blindness because of eye disease or injury can benefit from cornea transplant. Bone transplantation is used to cure patients suffering from bone deformity due to ageing or other birth defects. It can also help victims who have to undergo amputations and accident victims whose bones may have got damaged beyond repair.  

Even though tissue transplantation is currently being performed at several public and private health care facilities in the country, with the amended Act a standard medical procedure for performing tissue transplantation will be established, says Sanjay K Agarwal, head of nephrology department at the All India Institute of Medical Sciences (AIIMS) in Delhi. He adds that sets of protocols of how each tissue is to be transplanted will be formulated in the rules.  

Though no reports on commercial dealing of tissues have come to the health ministry’s notice officially, the need to amend the Act to add tissues arose to make it more comprehensive. “Adding tissues in the Act is a step to improve the quality of treatment that is offered to the patients undergoing transplantation. At present there is no proper system for tissue transplantation that ensures that a diseased person’s tissue is not given to the recipient,” says Gupta. “We want to expand the organ transplantation law. We have included tissues and in future we will include cells as well under the act,” he adds.  

“Some tissues like heart valves, skin, bone cartilages and vessels can be retrieved even from the mortuary. When there is a demand for such tissues, commerce can very easily creep into the system. Hence regulatory mechanism needs to be in place,” says Sunil Shroff, managing trustee of MOHAN Foundation, a non-profit to promote organ donation.  

Challenges of framing rules

Meanwhile, the task of drafting rules for various tissues is challenging as all tissues that can be retrieved and transplanted have different procedures for retrieval, storage and transplantation. 

Unlike in organ donation, tissues cannot be taken from a living person. Live donors can give one kidney or a part of the liver to save the lives of their patients, but if a person’s skin, heart valve or bones are needed, these can only be retrieved from a deceased donor. Deceased donor here means a person who is declared brain dead or who has suffered cardiac death. In cases where a person dies of cardiac death, the time period for retrieval of tissues and organs is very short and retrieval of organs from such patients happens mostly in hospitals, if at all, informs Agarwal.  

Tissues retrieved from one deceased person can benefit hundreds of people. To make optimum use of tissues donated in the country, a strong networking is required between all tissue transplantation centres to keep a record of where each tissue retrieved is going and to ensure it is not used for commercial purposes, as is the aim of the Act, stresses Harsha Jauhari, chairperson of renal transplant surgery department at Sir Ganga Ram Hospital. 

The advantage with tissue transplantation is that tissues can be stored and used whenever there is a requirement. Tissues can be collected from the donor and investigated to see if they are free from infections. They are then sterilized and stored for months together. Tissues can also be transported to different parts of the country, which is not possible for organs. Once an organ is retrieved, it has to be immediately transplanted.  

A tissue like cornea can be retrieved from a body within six hours of death of the person and within 24 hours if the body is kept in cold storage. It is stored in a liquid medium in a refrigerator in an eye bank. It can be stored only for 96 hours. If not used until then, it will have to be discarded. With the help of an improved medium of storing, cornea can be stored for two weeks. But this is an expensive method and is not used widely.   

Similarly, bones can be retrieved within 24 hours from a deceased donor if the body is preserved. If the body is not preserved, the doctor can refuse to use the bones as the process of decaying starts immediately. The retrieved bones are tested if they are disease free, sterilized, exposed to gamma radiation and then frozen. A frozen bone has a shelf life of up to five years.   

At present, there are no estimates available for the need of tissue transplantation in India, except for cornea. But the doctors agree the need for such surgeries is huge. “Bone is the most widely used tissue after blood worldwide. So the demand for bone transplantation is huge,” says Rajesh Chandra, orthopedic surgeon at Safdarjang Hospital.  

Where are the donors?

However, the ambitious Act may fail to achieve the desired result due to lack of deceased donors of tissues in India, as is the problem with organ donation.  

From the data collected for the year 2010 by various hospitals in the country, India needs 175,000 kidney transplants, but due to lack of facilities and donors, only 5,000 transplants are carried out. Similarly, 50,000 liver transplants are needed, but only 700 surgeries are conducted. Only 30 hearts were transplanted as against the need of 50,000. For transplanting cornea, 100,000 surgeries are needed but only 25,000 are conducted.  

This soaring need for organ transplantation is met only through the government approved 200 kidney transplant centres, 30 liver transplant centres and only 10 cardiac transplant centres across the country. Shortage of skilled manpower is also the reason why government’s programme is not picking pace. India has only 200 kidney transplant surgeons, 25 liver transplant surgeons and 15 cardiac transplant surgeons.  

With high cost of treatment, only few of the needy can afford organ transplant. For kidney transplant, the cost borne by a government hospital per patient is Rs 30,000, for cardiac transplant it is Rs 40,000 and for liver transplant it is Rs 15 lakh. The cost of the same medical treatment in private hospitals is several times higher, informs Agarwal.  

“Out of all human organ transplant surgeries conducted in the country, 90 per cent are conducted at private hospitals and only 10 per cent are at the government hospitals,” says A S Soin, liver transplant surgeon at Medanta –The Medicity in Gurgaon near Delhi. He stresses there is a need to strengthen such centres run by the government so that the poor who are in need of transplantation can also benefit from it.  

To enhance the infrastructure to strengthen the Act, on November 26, India got its first coordination centre for organ and tissue transplantation, called the Model Organ Procurement and Distribution Organisation (MOPDO) at the Safdarjang Hospital. This centre will collect records of organ and tissue donors and recipients from states and maintain a database of the need of organs and tissues for transplantation. This will also be the central coordinating centre.  

Under the new Act, all hospitals that are performing tissue transplantation or wish to perform such medical procedures will have to approach the appropriate authority under the director general of health services in the Union health ministry within 60 days of President’s assent to the bill. The appropriate authority will then send a team of doctors and other experts to that hospital to inspect the facilities available for tissue transplantation. If the hospital meets the criteria set by the government, only then will it be certified as a centre for tissue transplantation. Once the rules are notified under the Act, if a hospital that doesn’t have the approval from the government performs tissue transplantation, it could be heavily penalised.  

Since cornea is now categorized as a tissue and not an organ under the Act, the standards for organ transplantation, which were applicable for cornea as well up till now, will be eased. A retrieved cornea need not go a living relative of the donor, says Radhika Tandon, professor of ophthalmology at AIIMS.  

Also, under the new rules of the Act, a trained nurse or a technician would now be allowed to retrieve cornea in case a doctor is not available. “Harvesting of cornea is done after the donor has died and it is a simple procedure. The absence of a doctor would not be a limiting factor in retrieving cornea now,” she says.  

A national programme for organ donation, called the national organ transplant programme, is already running in the country with Rs 600 crore already approved for it. But with a severe shortage of organ donors and negligible infrastructure transplantation in the country, tissue transplantation may lie in limbo unless tissue donors increase.  

Supply short of demand 

According to Data collected for the year 2010 by various hospitals in the country: 

• India needs 175,000 kidney transplants, but due to lack of facilities and donors, only 5,000 transplants are done. 

• 50,000 liver transplants are needed but only 700 surgeries are conducted 

• Only 30 hearts were transplanted as against the need of 50,000 

• For transplanting cornea, 100,000 surgeries were needed but only 25,000 were conducted

• There are only 200 government approved kidney transplant centres, 30 liver transplant centres and 10 cardiac transplant centres across India 

• India has only 200 kidney transplant surgeons, 25 liver transplant surgeons and 15 cardiac transplant surgeons 

Beneficiaries of tissue transplant

• Skin transplant is needed for victims of severe burns 

• People suffering from blindness because of eye disease or injury can benefit from cornea transplant 

• Bone transplantation is used to cure patients suffering from bone deformity due to ageing or other birth defects. It can also help victims who have to undergo amputations and accident victims whose bones may have got damaged beyond repair. 

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